MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INGENIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number K184

Device Problems Battery Problem (2885); Inappropriate or Unexpected Reset (2959)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2023

Event Type  Injury  

Event Description

It was reported that the remaining longevity for this implantable pulse generator decreased from 3 years to 1.5 years over the past year.Data analysis identified an unexpected reset, and confirmed the voltage is decreasing faster than expected.A boston scientific technical services consultant discussed the results with the health care professional.This patient is dependent and device replacement will be scheduled urgently.The device remains implanted at this time and no replacement details are available.No adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that the remaining longevity for this implantable pulse generator decreased from 3 years to 1.5 years over the past year.Data analysis identified an unexpected reset, and confirmed the voltage is decreasing faster than expected.A boston scientific technical services consultant discussed the results with the health care professional.This patient is dependent and device replacement will be scheduled urgently.The device remains implanted at this time and no replacement details are available.No adverse patient effects were reported.Additional information was received that this device was subsequently explanted and will be returned for evaluation.No additional adverse patient effects were reported.

Event Description

It was reported that the remaining longevity for this implantable pulse generator decreased from 3 years to 1.5 years over the past year.Data analysis identified an unexpected reset, and confirmed the voltage is decreasing faster than expected.A boston scientific technical services consultant discussed the results with the health care professional.This patient is dependent and device replacement will be scheduled urgently.The device remains implanted at this time and no replacement details are available.No adverse patient effects were reported.Additional information was received that this device was subsequently explanted and will be returned for evaluation.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device determined it had undergone resets.The system resets occurred during a telemetry session.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: INGENIO
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17715655
• MDR Text Key: 323278951
• Report Number: 2124215-2023-49146
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/17/2014
• Device Model Number: K184
• Device Catalogue Number: K184
• Device Lot Number: 112175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 09/11/2023; 02/28/2024
• Supplement Dates FDA Received: 09/15/2023; 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male